SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container
- Name:
SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container
- Company:
Santen UK Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/12/17
(Click to Download)XPIL
Package leaflet: Information for the patient
Package leaflet: Information for the patient
1. What SAFLUTAN is and what it is used for
1. What SAFLUTAN is and what it is used for
2. What you need to know before you use SAFLUTAN
2. What you need to know before you use SAFLUTAN
3. How to use SAFLUTAN
3. How to use SAFLUTAN
4. Possible side effects
4. Possible side effects
5. How to store SAFLUTAN
5. How to store SAFLUTAN
6. Contents of the pack and other information
6. Contents of the pack and other information
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Santen UK Limited
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 11 December 2017 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
…
There is a potential for hair growth to occur in areas where tafluprost solution comes repeatedly in contact with the skin surface.
…
4.8 Undesirable effects
…
Eye disorders
…
Not known (cannot be estimated from the available data): iritis/uveitis, lid sulcus deepened, macular oedema/cystoid macular oedema.
…
10 DATE OF REVISION OF THE TEXT
July 2015
November 2017
Updated on 11 December 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 December 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 7 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 4 January 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 4 January 2016 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)